REPLACE: Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? A RCT

Asthma Clinical Trial

Official title:

REPLACE: Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290898
• Other study ID #: REPLACE
• Status: Completed
• Phase: N/A
• Start date: October 13, 2017
• Est. completion date: December 4, 2020

Study information

• Verified date: March 2021
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate if physical exercise intervention leads to an improved asthma control as measured by Asthma Control Questionnaire (ACQ-5) in such a magnitude that inhaled corticosteroid can be reduces in asthmatics.

Description:

At least 102 asthmatics will be randomized 2:1 (2 to training group; 1 to control) and undergo 6 months of intervention or usual lifestyle.

Subjects must have confirmed asthma diagnosis, on a stable treatment with inhaled corticosteroid, symptomatic and untrained.

At enrollment and during the study asthma medicine is adjusted based on asthma symptoms evaluated by ACQ-5. 6 treatment steps are pre-defined, and if well controlled asthma, subjects are down-titrated one step, if uncontrolled, subjects are uptitrated one step.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 4, 2020
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Asthma (The diagnose of asthma is based on symptoms and at least one positive asthma test the last 5 years (AHR to either mannitol or methacholine, reversibility to beta2-agonist, peak flow variation or positive eucapnic voluntary hyperventilation test))

• ACQ = 1 and = 2.5

• On a daily dose of ICS at a minimum of 400 µg budesonide or equivalent ICS for 3 months and with no changes in asthma medicine 4 weeks prior to enrollment

• Untrained (no participation in vigorous exercise for more than 1 hour per week during the last 2 month)

• Capable of exercising on bike

Exclusion Criteria:

• Unable to speak and understand Danish

• Infection within 4 weeks prior to visit 100*

• Asthma exacerbation within 4 weeks prior to visit 100*

• Hospitalized for an asthma attack during the last 2 months

• Treatment with immunotherapy within 5 T½ of the treatment drug prior to visit 100

• Initiation of allergen immunotherapy within 3 months prior to visit 100 or plan to begin therapy during study period

• Treatment with peroral prednisolone

• Respiratory: other chronic pulmonary disease of clinically significance

• Cardiovascular: Unstable ischemic heart disease, myocardial infarction within the last 12 months, symptomatic heart failure (NYHA III-IV or EF <40%), symptomatic heart arrhythmia (documented with ECG), uncontrolled hypertension (>155/100)

• Pregnancy or breastfeeding or planned pregnancy within the next 12 months

• Other inflammatory or metabolic diseases with the exception of rhinitis, atopy and well-controlled hypothyroidism treated with or without Eltroxin

• Vaccination less than 2 weeks prior to any visit

• Current or former smokers with > 20 pack years

• Subjects, who by investigators determination, will not be able to adhere to study protocol

• If patients are excluded due to a recent infection or exacerbation they can undergo re-screening after a total of 4 weeks after end of exacerbation treatment/clearing the infection.

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• High Intensity Interval Training
Training (HIIT)

Locations

Country	Name	City	State
Denmark	Respiratory Research Unit, Birpebjerg Hospital	Copenhagen NV

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Eosinophilic subpopulation - exploratory analyses 6 months	To evaluate the effect of the intervention in sub-populations of asthmatics using different cut-off values of blood eosinophilics. Both regarding primary outcome and secondary outcomes.	6 months +/- 7 days
Other	Eosinophilic subpopulation - exploratory analyses 12 months	To evaluate the effect of the intervention in sub-populations of asthmatics using different cut-off values of blood eosinophilics with regards to secondary outcomes at 12 months.	12 months +/- 7 days
Primary	Reduced inhaled corticosteroid (ICS) 6 months	The proportion of participants at 6 months that have been down-titrated in ICS dose by at least 25% compared to the participants' baseline dose	6 months +/- 7 days
Secondary	Reduced inhaled corticosteroid (ICS) 12 months	The proportion of participants at 12 months that have been down-titrated in ICS dose by at least 25 % compared to baseline.	12 months +/- 7 days
Secondary	Cumulated ICS 6 months	Change from baseline in cumulated dose of ICS at 6 months	6 months +/- 7 days
Secondary	Cumulated ICS 12 months	Change from baseline in cumulated dose of ICS at 12 months	12 months +/- 7 days
Secondary	Cumulated Long acting beta2 agonists (LABA) 6 months	Change from baseline in cumulated dose of LABA at 6 months	6 months +/- 7 days
Secondary	Cumulated LABA 12 months	Change from baseline in cumulated dose of LABA at 12 months	12 months +/- 7 days
Secondary	Exacerbation rate 6 months	Number of exacerbations (moderate-severe) at 6 months	6 months +/- 7 days
Secondary	Exacerbation rate 12 months	Number of exacerbations (moderate-severe) at 12 months	12 months +/- 7 days
Secondary	miniAQLQ 6 months	Change from baseline in Asthma life quality evaluated by miniAQLQ at 6 months	6 months +/- 7 days
Secondary	miniAQLQ 12 months	Change from baseline in Asthma life quality evaluated by miniAQLQ at 12 months	12 months +/- 7 days
Secondary	Fraction of exhaled Nitrogen Oxid 6 months	Change from baseline in Airway inflammation evaluated by FeNO at 6 months	6 months +/- 7 days
Secondary	Fraction of exhaled Nitrogen Oxid 12 months	Change from baseline in Airway inflammation evaluated by FeNO at 12 months	12 months +/- 7 days
Secondary	Sputum cell count 6 months	Change from baseline in Airway inflammation evaluated by sputum cell count at 6 months	6 months +/- 7 days
Secondary	Sputum cell count 12 months	Change from baseline in Airway inflammation evaluated by sputum cell count at 12 months	12 months +/- 7 days
Secondary	Systemic inflammation 6 months	Change from baseline in systemic inflammation evaluated by blood eosinophilic, hsCRP and inflammatory cytokines (e.g. IL-6 and IL-8) and TNF-alfa at 6 months	6 months +/- 7 days
Secondary	Systemic inflammation 12 months	Change from baseline in systemic inflammation evaluated by blood eosinophilic, hsCRP and inflammatory cytokines (e.g. IL-6 and IL-8) and TNF-alfa at 12 months	12 months +/- 7 days
Secondary	Airway hyperresponsiveness	Change from baseline in airway hyperresponsiveness measured by methacholine test at 6 months	6 months +/- 7 days
Secondary	FEV1 6 months	Change from baseline in lung function evaluated by FEV1 at 6 months	6 months +/- 7 days
Secondary	FVC 6 months	Change from baseline in lung function evaluated by FVC at 6 months	6 months +/- 7 days
Secondary	FEV1 12 months	Change from baseline in lung function evaluated by FEV1 at 12 months	12 months +/- 7 days
Secondary	FVC 12 months	Change from baseline in lung function evaluated by FVC at 12 months	12 months +/- 7 days
Secondary	Cardiopulmonary fitness	Change from baseline in cardiopulmonary fitness evaluated by maximum oxygen consumption at 6 months (VO2max)	6 months +/- 7 days
Secondary	Change in fat and muscle composition (DEXA scan)	Change from baseline in fat and muscle composition evaluated by DEXA scan	6 months +/- 7 days